The term dietary supplement was formally defined by U.S. Government office in 1994 as a product (other than tobacco) intended to supplement the diet to enhance health that bears or contains one or more of the dietary ingredients viz.: vitamins, minerals, amino acids, herbs or other botanicals or a dietary substance for use to supplement the diet by increasing the total dietary intake, and is intended for ingestion in the form of capsule, powder, soft gel, gel capsule and not represented as a conventional food or as a sole item of a meal or the diet. [Dietary supplement Health and Education Act (DSHEA) Public Law 103-417, Oct. 25, 1994; codified at 42 use 287C-11].
Mental makeup of the people depend considerably on the food articles which they consume and it is very well illustrated by a set of verses in the Hindu""s famous religious book Bhagwat Gita XVIII 8-10. The lactating mothers require a very nutritive diet to keep them fit after the delivery. At the height of lactation 1.5 liters of milk may be formed each day. With this degree of lactation, great quantities of metabolic substrates are drained. 50 grams of fat enters the milk each day, approximately 100 grams of lactose derived from glucose is lost, 2-3 gm. calcium phosphate producing decalcification of bone specific problem during lactation. [A. C. Guyton: Textbook of Medical Physiology W. B., Saunders Company West Washington Square Philadelphia Pa. 19105 PP. 996 1986]. General dietary habits are not sufficient to fulfil the requirement of all nutrients of the body. The secretion of milk requires energy and the body has three folds demand for calories during lactation. There is need of sufficient fuel to permit the women to carry out the ordinary day to day activities. Activity of the mammary glands and energy content of milk secreted are the two important requirements. The inefficiency of some women in converting food into milk has been found to be crucial at the time of specific function of lactation. Loss of weight during lactation is fairly common, with women with malnutrition.
To maintain harmonious balance between the different aspects of life, the quality of food improved considerably in terms of its food value and taste with the advancement of civilization. Preventive measures are probably the most effective method of dealing with these conditions and such measures should include diet and dietary supplements. Many neutraceutical compositions, health foods, drinks and supplements are available in the market but only few compositions/products are available in form of neutraceutical biscuits especially for lactating mothers.
Theraptein manufactured and marketed by Raptakos, Brett and Co. Ltd. MIC. DHA TV Rocha 40211160, Velacheri Road, Chennai, India contains following ingredients for 5 gm (approximate) Protein (mainly casein) 1.5 gm, Carbohydrate 2.4 gm, Fat 0.7 gm, Thiamine hydrochloride 0.25 mg, Riboflavin 0.25 mg, Nicotinamide 0.25 mg, 22 calories per biscuit intact protein. It claims to supply vital protein of high biological value. It is useful for those who due to illness or faulty dietary habit, do not take sufficient amount of protein and make up quantitatively and qualitatively the protein exhaustion, common to house wives, school going children and business and professional men.
Second brand name xe2x80x9cGRD Bixxe2x80x9d biscuits manufactured and marketed by Cadila Health Care Ltd. 16, Azad Society Ambawadi, Ahmedabad 380015 contains following ingredients per 5 gm approximate Protein (mainly casein) 1.4 gm, Fat 0.7 gm, Carbohydrate 2 gm, Calcium 40 mg, Phosphorus 38 mg, Iron 100 mg, Vitamin A 266 I.D., Vitamin D 17 I.U., Nicotinamide 2.5 mg, Vitamin B2 225 mg, Vitamin B1 165 mg, Vitamin B6 50 mg, Folic acid 0.8 mg, Vitamin B12 0.8 mg, Copper 20 mg, Manganese 1.2 mg, Zinc 75 mg. It is recommended as a nutritional supplement for under weight, general ill health for aged, growing children, teenagers, athletes, travelers, businessmen, pregnant women and lactating mothers.
These biscuits have been enriched adding nutritional ingredients from synthetic sources. However nothing has been supplemented to increase the secretion of mammary gland for those women who are not very much efficient of converting food into milk. These drawbacks have been over come in the present composition of sweet biscuits made up of mixtures of natural ingredients.
The main object of the present invention is to develop a composition of herbal biscuits for lactating mothers, which acts as dietary supplement and process for the preparation thereof.
Another object of the invention is to provide a composition, which activates and regulates the secretion of mammary glands to increase lactation.
Yet another object of the invention is to provide a composition which improves the digestion and appetite of the lactating mothers by regulating the metabolic activities.
Yet another object of the invention is to provide a composition, which improves the adaptogenic, and imunomodulating systems of the body to reduce the stress and feeling of fatigue which is very much common amongst the lactating mothers.
Yet another object of the invention is to provide a composition to act as a preventive and rejuvenative nutritive supplement.
The present invention relates to a composition of herbal biscuits for lactating mothers acting as dietary supplement and the process for the preparation thereof. The composition of the present invention has nutritive digestive, stimulant and appetite improving properties attributed to a polyherbal composition of many natural herbs along with nutritive flours which not only compensate the essential dietary requirements of lactating mothers, but also act as a preventive and rejuvenate health supplement which relieves stress and fatigue in daily life.
To meet the above objectives, the present invention provides a composition of herbal biscuits for lactating mothers acting as a dietary supplement and a process for the preparation of the composition.
The invention provides a herbal dietary supplement composition for lactating mothers, said composition comprising required quantum of one or more herbs selected from each of Group A to Group D, wherein the herbs form Group A comprising medicinal plant materials having galactagogue properties, Group B comprising medicinal plant materials having adaptogenic and anti-stress properties, Group C comprising medicinal plant materials having hepatoprotective properties and Group D comprising medicinal plant materials having digestive and appetite improving properties, along with required quantum of additives selected from nutritive flour and optional frying, flavoring, coloring and dressing agents (Table 1).
Table 1 contains nutritive flours of Soyabean, Buckwheat, Moong, Wheat, Bazra, Bengal gram along with Carrot juice in combination with many plants having (A) Galactagogue (lactogenic) properties, (B) Adaptogenic and imunomodulating properties, (C) Hepatoprotective properties and (D) digestive and appetite improving properties along with Piper longum (Pippali), and Piper nigrum (Kali mirch) which enhances the absorption of these drugs in the body system. The natural preservative like Curcuma longa (Haldi) has been added in the preparation, which besides its versatile medicinal properties bears good preservative activities due to its strong antioxidant and antimicrobial activities.
Further, the present invention provides a composition for preparing herbal biscuits, nugget or powder for lactating mothers acting as dietary supplement and the process for the preparation thereof. This process comprising:
(i) frying of 0.25-0.5 g. Curcuma longa powder in 0.5-1 g. purified butter for 5-10 minutes until it turns brown;
(ii) adding of 40-60 g. nutritive flour along with 0.25-0.5 g. purified butter (ghee) and frying the mixture to become pink, keeping it to room temperature;
(iii) adding 15-18 g. sweetening agent along with powdered form of one or more therapeutic herbs selected from Groups A, B and C plants in ratio 3:4:2 along with 1 g. each of the medicinal spices of group D from nos. 1-5;
(iv) homogenizing the mixture thoroughly and adding fresh carrot juice 30-45 ml, making it as a paste;
(v) molding in different sizes and dressing with cardamom seed or poppy seeds; and
(vi) baking at temperature 140-150xc2x0 C. for 5-7 minutes.
The preferred composition of present invention comprises preparation of a phytomedicinal composition of therapeutic herbs of groups A, B and C plants in the ratio of 3.5:4.5:2. The plants were cleaned, washed with water and shade dried. All the plant materials were powdered and sieved separately. The plant powders were mixed in above ratio by weight in the amount mentioned against each and homogenized.
The plant material from Group A having lactogenic properties, like Asparagus racemosa 1.5-4 gm, Amaranthus spinosa 0.5-2 gm and Carum carvi .5-1 gm, and plant from Group B having adaptogenic and imunomodulating properties Withania somnifera 3-5 gm, Picrorrhiza Kurroa .5-2 gm, Bacopa monniera 1-2 gm and Tinospora cardifolia .5-2 gm and plants from Group C having hepatoprotective properties Glycyrrhiza glabra 2-4 gm, Eclipta alba .5-1 gm and Boerhavia diffusa 1-2 gm. In second step 0.25-5 gm Curcuma longa powder is fried lightly in frying pan with .5-1 gm Ghee or purified butter. Powders of seeds of Nelumbo nuciflora (Kamal gatta) 2-5 gm and Sesamum indicum seed 1-2 gm are added with nutritive flours prepared by mixing wheat flour 15-18 gm with soya flour 7-10 gm, Bengal gram 2-4.5 gm buck wheat 5-8 gm and powdered leaves of Moringa oleifera (Sahajan) 3-7 gm. This is fried on medium heat for 5 to 10 minutes in 1.5 gm Ghee with constant stirring till light pink colour is obtained. To the fried material 18 gm powdered sugar or date sugar was added and mixture was homogenized in a mixture grinder along with phytomedical composition of therapeutic herbs prepared in first step, and followed by addition of ground mixture of Piper longum, Piper nigrum, Terminalia chebula Zingiber officinale and Trachyspermum ammi (one gm each) and again homogenized till the mixture was uniform. Homogeneous mixture thus prepared is made into a paste with the help of fresh carrot juice 20-35 ml and spread into 0.2-0.3 cm thick layer with the help of a thinner and cut into small rounded diskettes by a mold. Finally ground cardamom is sprinkled on this diskettes and baked in an oven. The biscuits thus prepared are wrapped in waxy paper to protect from moisture.
In an embodiment of the invention the plants having lactogenic properties are selected from group A comprising of the plants namely Amaranthus spinosa, Leptadenia reticulata, Ziziphus moritiana, Nigella sativa, Chenopodium ambrosides, Ferula aesfotida and Grewia hirsuta. 
In another embodiment, plants having of adaptogenic and imunomodulating properties are selected from Group B comprising of the plants namely Withania somnifera, Boerhaavia diffusa, Bacopa monniera, Tinospora cordifolia, Diospyrus peregrina, Albizzia lebeck and Cissompelos pareira. 
In yet another embodiment of the present invention the plants having of hepatoprotective activities are selected from the group C comprising of the plants Fumaria parviflora, Glycyrrhiza glabra, Boerhaavia diffusa, Phyllanthus amarus, Eclipta alba, Piper longum, Tephrosia purpurea, Ocimum sanctum, Picrorrhiza Kurroa, Andrographis paniculata and are selected in respective ratio of the group.
In another embodiment of the invention only wheat flour along with leaves of Moringa oleifera is mixed or flours i.e. soya (Glycine max), buck wheat (Fagopyrum esculentum), green gram (Vigna radiata) or Bengal gram (Cicer arientinum) is incorporated in the composition.
In another embodiment of the invention, the sweetening agent is selected from sugar, date sugar or any other sweetening agent.
In yet another embodiment of the invention, the composition is prepared as powder, biscuit, capsule, nugget, gel or any other forms, which can be taken with water, milk or other liquid foods.
In yet other embodiment of the invention powder from the members of group B plants having adaptogenic imunomodulating properties i.e. Withania somnifera, Ocimum sanctum, Picrorrhiza kurroa, Sida cordifolia, Boerhaavia diffusa, Bacopa monniera, Tinospora cordifolia, Diospyrus peregrine, Albizzia lebeck, and Cissompelos pareira, which are selected as a nutrient food supplements for General health.
In still another embodiment of the invention members of various combinations of Group C plants having of hepatoprotective properties e.g. Glycyrrhiza glabra, Boerhaavia diffusa, Phyllanthus amarus, Eclipta alba, Piper longum, Tephrosia purpurea, Ocimum sanctum, Picrorrhiza kurroa, Andrographis paniculata, and Fumaria parviflora which are added as liver protective agents.
In yet another embodiment of the invention, single plant providing more than one property can be selected for example, Ocimum sanctum having adaptogenic and anti-stress activities also have hepatoprotective activities. In this case, that quantum of the single plant should be the required quantum or the pharmaceutically acceptable amount.
In yet another embodiment of the invention, medicinal plants Ocimum sanctum, Boerhaavia diffusa and Picrorrhiza kurroa having adaptogenic and anti-stress activities also have hepatoprotective activities.
In yet another embodiment of the invention, medicinal plant Piper longum is having hepatoprotective property as well as digestive and appetite improving activity.
In still another embodiment aspect of the invention dietary supplement for lactating women provides phytoestrogen, micronutrients, antioxidants and elements to enhance calcium absorption and utilization. The cumulative beneficial and preventive effects have been achieved by this dietary supplement.
The sum total of properties of composition is entirely different from its individual components. The different composition has been described and which are illustrated by following examples and therefore, should not be construed to limit the scope of invention.